Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000625976
Ethics application status
Approved
Date submitted
23/05/2011
Date registered
20/06/2011
Date last updated
25/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transdiagnostic Program 1 - The Anxiety Program: Internet based education for social phobia, panic disorder (with or without agoraphobia) and generalised anxiety disorder with telephone reminders and online forum support. A randomized controlled study
Scientific title
A randomized controlled trial of Internet based education for social phobia, panic disorder (with or without agoraphobia), and generalised anxiety disorder, comparing immediate education versus delayed education groups on severity of symptoms of anxiety.
Secondary ID [1] 262230 0
no
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia (an anxiety disorder) 236958 0
Panic disorder (with or without agoraphobia) (both anxiety disorders) 236959 0
Generalised anxiety disorder (an anxiety disorder) 236960 0
Condition category
Condition code
Mental Health 237307 237307 0 0
Anxiety
Mental Health 268076 268076 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) Immediate education group; or 2) Delayed education group. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for either social phobia and/or panic disorder (with or without agoraphobia) and/or generalised anxiety disorder. All participants will complete 6 lessons of Internet based education about managemnt of symptoms of anxiety. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about people with anxiety, taking a further 20 mins per summary. Participants in both groups will receive weekly reminder telephone calls, and have access to an online forum that will be moderated by the researchder to allow discussion of content of the program, during the treatment-phase of their participation. The duration of phone calls and forum participation is expected to be 2-7 mins. The duration of the program is 9 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-education, post-education, and at 3-months post-education. These will take about 20 minutes to complete. The educational materials are based on the Shyness, Panic and Worry Programs, which applies cognitive behavioural techniques.
Intervention code [1] 236734 0
Behaviour
Comparator / control treatment
Delayed eduction group will receive no contact during the 10 weeks then will be reassessed and then provided with internet based education for anxiety disorders with automatic email, weekly telephone reminders, and access to online discussion forums.
Control group
Active

Outcomes
Primary outcome [1] 238116 0
Anxiety Disorders are measured by the Mini International Psychiatric Interview
Timepoint [1] 238116 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [2] 238117 0
Anxiety is measured using the Beck Anxiety Inventory
Timepoint [2] 238117 0
Administered at pre-education, post-education, and at 3-months post-education.
Primary outcome [3] 238123 0
Neuroticism is measured using the NEO Five Factor Inventory
Timepoint [3] 238123 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [1] 242330 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 242330 0
Administered at application, pre-education, post-education, and at 3-months post-education.
Secondary outcome [2] 242331 0
Disability is measured by the Sheehan Disability Scale
Timepoint [2] 242331 0
Administered at application, pre-education, post-education, and at 3-months post-education.
Secondary outcome [3] 242332 0
Disability is measured by the World Health Organisation Disability Assessment Schedule II (WHODAS II)
Timepoint [3] 242332 0
Administered at application, pre-education, post-education, and at 3-months post-education.
Secondary outcome [4] 276437 0
Social phobia is measured using the Social Interaction Anxiety Scale
Timepoint [4] 276437 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [5] 276438 0
Panic disorder is measured using the Body Vigilance Scale
Timepoint [5] 276438 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [6] 276439 0
Agoraphobia is measured using the Agoraphobic Questionnaire
Timepoint [6] 276439 0
Administered at pre-education, post-education, and at 3-months post-education.
Secondary outcome [7] 276440 0
Generalised anxiety disorder is measured using the Generalised Anxiety Disorder Questionnaire (GAD-7)
Timepoint [7] 276440 0
Administered at pre-education, post-education, and at 3-months post-education.

Eligibility
Key inclusion criteria
Meet DSM-IV criteria for social phobia and/or panic disorder (with or without agoraphobia) and/or generalised anxiety disorder - Internet access + printer access. - Australian citizen- Males and females.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current substance abuse/dependence- Psychotic disorder- Current or planned psychological treatment during study duration- Change in medications during last 1 month or intended change during study duration. Use of benzodiazepines or beta-blockers.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply on line, followed by a telephone interview to confirm diagnosis via structured diagnostic interview (MINI 5.0.0). Participants will be randomized using a list generated prior to the study. Allocation concealment will occur by contacting the holder of the allocation schedule who is off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list will be generated prior to the study using computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2009
Actual
22/03/2010
Date of last participant enrolment
Anticipated
Actual
19/04/2010
Date of last data collection
Anticipated
Actual
18/10/2010
Sample size
Target
80
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 237133 0
University
Name [1] 237133 0
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Country [1] 237133 0
Australia
Primary sponsor type
University
Name
School of Psychiatry, University of New South Wales at St Vincent's Hospital
Address
299 Forbes Street Darlinghurst NSW2010
Country
Australia
Secondary sponsor category [1] 4623 0
Government body
Name [1] 4623 0
New South Wales Institute of Psychiatry
Address [1] 4623 0
Cumberland Hospital Fleet Street, North Parramatta, NSW 2151
Country [1] 4623 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239227 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 239227 0
Ethics committee country [1] 239227 0
Australia
Date submitted for ethics approval [1] 239227 0
04/02/2009
Approval date [1] 239227 0
17/02/2009
Ethics approval number [1] 239227 0
HREC 09029

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29722 0
Prof Gavin Andrews
Address 29722 0
Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 29722 0
Australia
Phone 29722 0
+612 8382 1400
Fax 29722 0
Email 29722 0
[email protected]
Contact person for public queries
Name 12969 0
Prof. Gavin Andrews
Address 12969 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 12969 0
Australia
Phone 12969 0
+61 2 83821726
Fax 12969 0
Email 12969 0
[email protected]
Contact person for scientific queries
Name 3897 0
Prof. Gavin Andrews
Address 3897 0
C/- Clinical Research Unit for Anxiety Disorders (CRUfAD) UNSW 299 Forbes Street Darlinghurst NSW 2010
Country 3897 0
Australia
Phone 3897 0
+61 2 83821405
Fax 3897 0
Email 3897 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.